Compliance & Validation

ValiTech supports your business goals throughout your medical device lifecycle.

Due to the critical nature of medical devices, there are strict FDA regulatory requirements regarding validation, which requires to be adhered to across all phases of the product lifecycle from Research & Development, Manufacturing, Logistics and Release for the end customer use. Regardless of the imposed regulatory requirements, a product developer and manufacturer will want to ensure that any devices sold on the markets, achieves the highest quality, reliability standards, performs as intended and meets the expectation of the medical staff or patients.

  • Concept
  • Planning
  • Design
  • Validation
  • Launcht
  • Post Market

Regardless of which phase of the product lifecycle you’re in, ValiTech can work with you to mitigate your technical and financial risks and ensure you remain compliant.

Our specialists demonstrate high standard and quality through:

  • Experience in the field of the medical devices.
  • Providing consultations and trainings to customer’s technical personnel.
  • Focused and flexibility on end customers business requirements.
  • Offering broad range of professional services.
  • Full compliance with ISO 13485 quality management systems.

Talk to us today to take advantage of our wide range of professional services.

NPI Engineering

  • Conceptual design and product develompet
  • Engineering support
  • Technical support
  • Launching
  • Production
  • Full compliance with standards

With the detailed technical support, proactive supply chain planning of the BOM’s components, established partnerships with a leading contract manufactures, regulatory and QC control, we are committed to developing your first fully functionin

Pilot Manufacturing

Pilot manufacturing is a critical step in full-scale of Medical and Industrial IoT device manufacturing. If your device is successful in pilot or clinical trials, it will likely transition to volume production. ValiTech engineers will support your project during entire process to avoid any flaws in the pilot manufacturing phase and to avoid a redesign or even rework of pilot batch. Therefore, you need to find an experienced technical consultant that will work on your behalf with a device manufacturing company to ensure compliance with SOPs, specs and the overall integrity of this process.

  • Design and production testing
  • Full-scale production

Pilot manufacturing is the process where medical devices and industrial IoT get tested in clinical trials before transitioning to volume manufacturing. During the pilot manufacturing process, our engineers will work closely with selected contract manufactures to elaborate product design, QA processes and iteratively implement all necessary changes before volume production, where design changes may become too costly and significantly delay your project. The pilot process includes: product design, process FMEA, plastic part design, material selection, design transfer to manufacturing, rapid prototyping, DHF, DMR, DHR, validation and verification (assembly, testing, tooling and fixtures, equipment validations, packaging, sterilization, accelerated age studies and transit testing).

Volume Manufacturing

Supply Chain for Medical
and Industrial IoT Devices

Establishing a well-managed supply chain is essential in every industry. Visibility into emerging product’s supply chain is a crucial tool for controlling costs throughout the company. In order to avoid inventory shortage that can result in severe repercussions for patients, medical and some Industrial IoT devices companies carry out high levels of inventory and are notorious for having low turnover. This strategy results in high costs of maintaining too much extra product, and loss of sales representative productivity from having to manage their “over-stock.”

To get around the increased costs and risk associated with the high-inventory approach, medical device companies are elaborating multiple supply chains and pursuing operational – efficiency opportunities to guarantee cost reduction.
Selected Medical Devices and Industrial IoT contract manufacturers are implementing solutions that offer real-time visibility into on-hand inventory, production schedules and order commitments. Demand and supply chain planning solutions that provide accurate forecasts and enhanced mobile capabilities allow for significant reductions in inventory while maintaining end customer service metrics to meet commitments.

  • Supply for medical and industrial devices
  • Customers
  • Process and costoptimization
  • Production control

ValiTech’s supply chain specialists work closely with our customers to thoroughly plan all the stages of supply chain medical devices and optimize processes and costs. We also work with Tier 1 contract manufacturers and Logistics companies who are audited by ValiTech as well as Certified ISO 9001 and ISO 13485.

We build trust with customers based on results of cost effective supply chain solutions by close managing and controlling all phases of the supply chain (procurement, manufacturing and logistics processes) while remaining compliant with global GMP regulations.

Project Management

  • Managament
  • Budget
  • Specifications and tests
  • Monitoring
  • Planning and control
  • Supply
  • Design

Our experienced Project Managers working on multiple activities during the planning and execution of the project will cater to:

  • Creating a detailed project plan with tasks, milestones and critical activities.
  • Preparing a project budget with estimated expenditures, Cashflow and P&L analysis.
  • Working on Conceptual Design, Basic Design, and Final Detail Design.
  • Managing all Supply Chain with a focus on cost and schedule reduction activities.
  • Writing requirement specifications and handling tests and qualification.
  • Monitoring Project’s KPIs: Planned Value (PV), Earned Value (EV), Actual Cost (AC), Cost Variance (CV), Cost Performance Index (CPI), Return on Investment (ROI).
  • Managing Project’s stakeholders such as consultants, sub-contractors and suppliers.
  • Building a work plan (WBS) and preparing all relevant project’s planning documents, such as URS, SRS, SAD, SIT, UAT, BCP/DRP, BOD, DQ.
  • Risk Management with proactive risk mitigation activities during all phases of the project.
  • Supervising installation systems on customer’s sites according to approved design and contracts.

We develop end-to-end IoT , M2M solutions and handle an entire process from a start to the finish. Our R&D department has successfully delivered planned projects for multiple years, and adhere with ISO9001, ISO13485 guidelines.